RV013F

Dénomination commerciale

non renseigné

08800204300232

B-08800204300232

Numéro de référence/catalogue

RV013F

GS1

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The RADI FAST Flu-SC2-RSV Detection Kit is an in vitro diagnostic medical device, based on Real-time RT-PCR technology utilizing reverse-transcriptase (RT) reaction to convert RNA into complementary DNA (cDNA). The RADI FAST Flu-SC2-RSV Detection Kit qualitatively detects of RNA of Influenza virus and/or S/Orf1ab gene of SARS-CoV-2 and/or N gene of SARS-CoV-2 and/or RSV extracted from nasopharyngeal swab specimens to aid in the diagnosis of Influenza and/or SARS-CoV-2 and/or RSV infection. Among the 4 targets S and Orf1ab genes of SARS-CoV-2 are tagged to single dye (FAM), and N gene is tagged to Cy5.5. Influenza and RSV are tagged to HEX and Cy5 respectively. Positive results are indicative of Influenza and/or SARS-CoV-2 and/or RSV RNA detection, but may not represent the presence of transmissible virus. Negative results do not preclude Influenza and/or SARS-CoV-2 and/or RSV infection and should not be used as the sole basis for patient management decisions. Results must be combined with clinical observations, patient history, and epidemiological information.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0105070304INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS